n. INTEGRITY REQUIREMENTS

(1)

·

-.

CERTunCATIONOFCOMW~CEAGREEMENT BETWEEN THE

OFFICE OF INSPECTOR GENERAL OF THE }}EPARTMENT OF REALm AND HUMAN SERVICES

AND

LOUISIANA STATE UN VERSITY HEALm SCIENCE CENTER - SHREVEPORT I. PREAMBLE

Louisiana State University Health Science Center Shreveport, acting through the Board of Supervisors of Louisiana State University Agricultural and Mechanical College (LSU) hereby enters into this Certification of Compliance Agreement (CCA) with the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS). Contemporaneously with this CCA, LSU is entering into a Settlement Agreement with the United States ofAmerica, through the United States Department of Justice, Officc ofthe United States Attorney, Western District of Louisiana.

The effective date ofthis CCA shall be the date on which the final signatory ofthis CCA executes this CCA (Effective Date). Each one-year period, beginning with the one year period following the Effective Date, shall be referred to as a "Reporting Period."

n.

INTEGRITY REQUIREMENTS

LSD shall, for a period ofthree years from the Effective Date of this CCA: A. Continued Implementation of Compliance Program. LSU shall continue to implement its Compliance Program, as described in the attached Declaration (which is incorporated by reference

as

Appendix A), and continue to provide, at a

minimum,

the same level of resources currently provided, throughout this time period. LSD may amend its Compliance Program as it deems necessary, so long as those amendments are

consistent with the overall objective of ensuring compliance with the requirements of Medicare, Medicaid, and all other Federal health care programs, as defined in 42 U.S.C. §

1320a-7b(f).

B. Reporting of Overpayments. LSD shall promptly refund to the appropriate Federal health care program payor any identified Overpayment(s), or arrange for off-set of future payments due from payor. For purposes of this CCA, an "Overpayment" shall mean the amount of money LSU has received in excess of the amount due and payable under any Federal health care program requirements. If, at any time, LSD identifies or Louisiana State University Health Science Center 1

Certification ofCompliance Agreement May 21. 2009

(2)

learns of any Overpayment, LSD shall notifY the payor ~Medicare fiscal intermediary or carrier) within 30 days after identification of the Overpayment and take remedial steps within 60 days after identification (or such additional time as may be agreed to by the payor) to correct the problem~including preventing the underlying problem and the Overpayment from recurring. Also, within 30 days after identification of the

Overpayment, LSD shall repay the Overpayment to the appropriate payor to the extent such Overpayment has been quantified. Ifnot yet quantified, within 30 days after identification, LSD shall notity the payor of its efforts to quantity the Overpayment amount along with a schedule ofwhen such work is expected to be completed. Notification and repayment to the payor shall be done in accordance with the payor's policies and, for Medicare contractors, shall include the information contained on the Overpayment Refund Form, provided as Appendix B to this CCA. Notwithstanding the above, notification and repayment of any Overpayment amount that is routinely

reconciled or adjusted pursuant to policies and procedures established by the payor should be handled in accordance with such policies and procedures.

C. Reportable Events. LSD shall report to OrG in writing within 30 days after making a determination (after a reasonable opportunity to conduct an appropriate review or investigatio of the allegations) that there is a Reportable Event, which shall mean anything that involves: (1) a substantial Overpayment, (2) a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program for which penalties or exclusion may be authorized; or (3) the filing of a bankruptcy petition by LSD. In such report, LSD shall include the following information:

1. Ifthe Reportable Event results in an Overpayment, the report to GIG shall be made at the same time as the notification to the payor required in Section IT.B, and shall include all of the information on the Overpayment Refund Form, as well as:

a. the payor's name, address, and contact person to whom the Overpayment was sent; and

b. the date ofthe check and identification number (or electronic transaction number) by which the Overpayment was repaid/refunded; 2. a complete description ofthe Reportable Event, including the relevant facts, persons involved, and legal and Federal health care program

Louisiana State University Health Science Center 2

Certification ofCompliance Agreement May 21, 2009

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authorities implicated;

3. a description of LSD's actions taken to correct the Reportable Event; and

4. any further steps LSD plans to take to address the :& ortable Event and prevent it from recurring.

5. If the Reportable Events involves the filing of a bankruptcy petition, the report to the 010 shall include documentation ofthe filing and a description of any Federal health care program authorities implicated.

D. Notification ofOovernment Investigation or Legal Proceedings. Within 30 days after discovery, LSD shall notifY OIG, in writing, of any ongoing investigation or legal proce~dingknown to LSD conducted or brought by a governmental entity or its agents involving an allegation that LSD has committed a crime or has engaged in fraudulent activities. This notification shall include a description of the allegation, the identity of the investigating or prosecuting agency, and the status ofsuch investigation or legal proceeding. LSD shall also provide written notice to 010 within 30 days after the resolution of the matter, and shall provide DIG with a description of the findings and/or results of the investigation or proceedings, if any.

E. Annual Reporting Requirements. LSD shall submit to oro annually a report that sets forth the following information for each Reporting Period (Annual Report):

1. A description of any material amendments to its Compliance Program and the reasons for such changes;

2. Any changes to the level ofresources dedicated to its Compliance Program and the reasons for such changes;

3. A summary of all internal or external reviews, audits, Qr analyses of its Compliance Program (including, at a minimum, the objective of the review, audit, or analysis; the protocol or methodology for the review, audit, or analysis; and the results of the review, audit, or analysis) and any corrective action plans developed in response to such reviews, audits, or analyses; 4. A summary of all internal or external reviews, audits, or analyses related

Certification of Compliance Agreement May 21. 2009

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to billing for orthopedic surgical services provided by faculty physicians (including, at a minim~the objective ofthe review, audit, or analysis; the protocol or methodology for the review, audit, or analysis; and the results of the review, audit, or analysis) and any corrective action plans developed in response to such reviews, audits, or analyses;

5. A report of the aggregate Overpayments that have been returned to the Federal health care programs. Overpayment amounts shall be broken down into the following categories: inpatient Medicare, outpatient Medicare, Medicaid (report each state separately, if applicable), and other Federal health care Programs. Overpayment amounts that are routinely reconciled or adjusted pursuant to policies and procedures established by the payor do not need to be included in this aggregate Overpayment report; and

6. A

certification

by

the Compliance Officer that: (a) to the best ofhis or her knowledge, except as otherwise described in the Annual Report, LSD is in compliance with the requirements ofthis Section II; and (b) he or she has reviewed the Annual Report and has made reasonable inquiry regarding its content and believes that the information in the Annual Report is accurate and truthful.

The first Annual Report shall be received by GIG no later than 60 days after the end of the first Reporting Period. Subsequent Annual Reports s} all be received by DIG no later

than the anniversary date of the due date of the fIrst Annual Report.

F. NotifIcations and Submission ofAnnual Reports. Unless otherwise specifIed in writing after the Effective Date, all notifications and Annual Reports required under this CCA shall be submitted to the following addresses:

OIG:

Administrative and Civil Remedies Branch Office of Courisel to the Inspector General Office of Inspector General

U.S. Department of Health and Human Services Cohen Building, Room 5527

330 Independence Avenue, S.W. Washington, DC 20201

Certification of Compliance Agreement May 21. 2009

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Telephone: 202-619-2078 Facsimile: 202-205-0604

LSU: Susan Annstrong, Compliance Officer 1541 Kings Highway, Room l-K-54 Shreveport, LA 71103

(318) 675-8503-Telephone (318) 675-8520- Fax

Unless otherwise specified, all notifications and reports required by this CCA may be made by certified mail, overnight mail, hand delivery, or other means, provided that there is proof that such report or notification was received. For purposes of this requirement, internal facsimile confmnation sheets do not constitute proof ofreceipt.

G. OIG Inspection.. Audit, -and Review Rights. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may examine or request copies ofLSU's books, records, and other documents and supporting materials and/or conduct on-site reviews of any ofLSU's locations for the purpose of verifying and evaluating: (a) LSD's compliance with the terms of this CCA; and (b) LSU's compliance with the requirements ofthe Fedeml health care programs in which it participates. The documentation described above shall be made available by LSU to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any ofLSD's employees, contractors, or agents who consent to be interviewed at the individual's place of business during normal business hours or at sueh other place and time as may be mutually agreed upon between the individual and OIG. LSD shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG's request. LSD's employees may elect to be interviewed with or without a representative of LSU present.

H. Document and Record Retention. LSD shall maintain for inspection all documents and records relating to reimbursement from the Federal health care programs, or to compliance with this CCA, for four years (or longer if otherwise required by law) from the Effective Date.

Ill. BREACH AND DEFAULT PROVISIONS

LSD is expected to fully and timely comply with all ofthe Integrity Requirements Louisiana State University Health Science center 5

Certification of Compliance Agreement

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set forth in this CCA.

A. Stipulated Penalties for Failure to Comply with Certain Obligations. As a contractuafremedy, LSD and OIG hereby agree that failure to comply with the Integrity Requirements set forth in this CCA may lead to the imposition of the following monetary penalties (hereinafter referred to as "Stipulated Penalties") in accordance with the

following provisions.

1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day after the date the obligation became due) for each day LSD fails to establish and

implement any of the following compliance program elements as described in Section II and the Declaration attached to this CCA as Appendix A:

a. a Compliance Officer; b. a Compliance Committee; c. a written Code of Conduct; d. written Policies and Procedures;

e. the annual training of owners, officers, directors, contractors, subcontractors, agents, medical staff, employees, and other persons who provide patient care items or services or who perform billing or coding functions on behalf ofLSU;

f. an internal audit department that performs periodic reviews to monitor LSD's compliance with Federal health care program requirements; said requirement may be satisfied by utilization of properly trained and credentialed compliance department staff; g. a Disclosure Program;

h. Ineligible Persons screening and removal requirements; and i. notification of government investigations and legal proceedings. 2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day Louisiana State University Health Science center 6

(7)

after the date the obligation became due) for each day LSD fails to submit the Annual Reports to 010 in accordance with the requirements of Section n.E by the stated deadlines for submissio .

3. A Stipulated Penalty of$1,500 for each.day LSD fails to grant access as required in Section n.o ofthis CCA. (This Stipulated Penalty shall begin to accrue on the date LSD fails to grant access.)

4. A Stipulated Penalty of$5,000 for each false certification submitted by or on behalf of LSD as part of its Annual Reports or otherwise required by this CCA.

5. A Stipulated Penalty of$l,OOO for each day LSD fails to comply fully and adequately with any Integrity Requirements of this CCA. 010 shall provide notice to LSD stating the specific grounds for its determination that LSD has failed to comply fully and adequately with the Integrity Requirement(s) at issue and steps LSD shall take to comply with the Integrity Requirements of this CCA. (This Stipulated Penalty shall begin to accrue 10 days after LSD receives notice from OIG of the failure to comply.) A

Stipulated Penalty as described in this Subsection shall not be demanded for any violation for which oro has sought a Stipulated Penalty under Subsections 1-4 of this Section

rnA.

B. Timely Written Requests for Extensions. LSD may, in advance ofthe due date, submit a timely written request for an extension of time to perform any act or file any notification or report required by this CCA. Notwithstanding any other provision in this Section, if010 grants the timely written request with respect to an act, notification, or report, Stipulated Penalties for failure to perform the act or fue the notification or report shall not begin to accrue until one day after LSD fails to meet the revised deadline set by OIG. Notwithstanding any other provision in this Section, ifOIG denies such a timely written request, Stipulated Penalties for failure to perfonn the act or file the notification or report shall not begin to accrue until three business days after LSD receives OIG's written denial of s ch request or the original due date, whichever is later. A "timely written request" is defined as a request in writing received by OIG at least five business days priorto the date by which any act is due to be perfonned or any notification or report is due to be filed.

C. Payment of Stipulated Penalties.

1. Demand Letter. Upon a finding that LSD has failed to comply with any

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ofthe obligations described in Section ilIA and after detennining that Stipulated

Penalties are appropriate, OIG shall notify LSD of: (a) LSD's failure to comply; and (b) DIG's exercise ofits contractual right to demand payment of the Stipulated Penalties (this notification is referred to as the 4'Demand Letter").

2. Response to Demand Letter. Within 10 days after the receipt of the Demand Letter, LSD shall either: (a) cure the breach to OIG's satisfaction and pay the applicable Stipulated Penalties or (b) request a hearing before an HHS administrative law judge (ALJ) to dispute DIG's determination ofnoncompliance, pursuant to the agreed upon provisions set forth below in Section TILE. In the event LSD elects to request an ALI hearing, the Stipulated 'Penalties shall continue to accrue until LSD cures, to DIG's satisfaction, the alleged breach in dispute. Failure to respond to the Demand Letter in one of these two manners within the allowed time period shall be considered a material breach of this CCA and shall be grounds for exclusion under Section m.D.

3. Form ofPayment. Payment of the Stipulated Penalties shall be made by electronic funds transfer to an account specified by DIG in the Demand Letter.

4. Independence from Material Breach Determination. Except as set forth in Section III.D.l.c, these provisions for payment of Stipulated Penalties shall not affect or otherwise set a standard for DIG's decision that LSD has materially breached this CCA, which decision shall be made at DIG's discretion and shall be governed by the provisions in Section m.D, below.

D. Exclusion for Material Breach of this CCA.

1. Definition ofMaterial Breach. A material breach of this CCA means: a. a failure by LSD to report a Reportable Event, take corrective action, and make the appropriate refunds, as required in Section

n.c;

b. a repeated or flagrant violation ofthe obligations under this CCA, including, but not limited to, the obligations addressed in Section ill.A; or

c. a failure to respond to a Demand Letter concerning the payment of Stipulated Penalties in accordance with Section III.C.

Louisiana State University Health Science Center 8 Certification of Compliance Agreement

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•

2. Notice ofMaterial Breach and Intent to Exclude.· The parties agree that a material breach ofthis CCA by LSD constitutes an independent basis for LSD's

exclusion from participation in the Federal health care programs. Upon a determination by OIG that LSD has materially breached this CCA and that exclusion is the appropriate remedy, OIG shall notify LSD of: (a) LSD's material breach; and (b) OIG's intent to exercise its contractual right to impose exclusion (this notification is referred to as the ''Notice of Material Breach and Intent to Exclude").

3. Opportunity to Cure. LSD shall have 30 days from the date ofreceipt of the Notice of Material Breach and Intent to Exclude to demonstrate to OIG's satisfaction that:

a. LSD is in compliance with the requirements of the CCA cited by 010 as being the basis for the material breach;

b. the alleged material breach has been cured; or

c. the aIleged material breach carmot be cured within the 30-day period, but that: (i) LSD has begun to take action to cure the

material breach; (ii) LSD is pursuing such action with due diligence; and (iii) LSD has provided to OIG a reasonable timetable for curing the material breach.

4. Exclusion Letter. If, at the conclusion ofthe 30-day period, LSD fails to satisfy the requirements of Section

IIID.3,

DIG may exclude LSD from participation in the Federal health care programs. DIG shall notify LSD in writing of its detennination to exclude LSD (this letter shall be referred to as the "Exclusion Letter''). Subject to the Dispute Resolution provisions in Section m.E, below, the exclusion shall go into effect 30 days after the date of LSD's receipt of the Exclusion Letter. The exclusion shall have national effect and shall also apply to all other Federal procurement and nonprocurement programs. ReinStatement to program participation is not automatic. After the end of the period of exclusion, LSD may apply for reinstatement by submitting a written request for reinstatement in accordance with the provisions at 42 C.F.R.. §§ 1001.3001-.3004.

Certification of Compliance Agreement May 21, 2009

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E. Dispute Resolution.

1. Review Rights. Upon DIG's delivery to LSU ofits Demand Letter or of its Exclusion Letter, and as an agreed-upon contractual remedy for the resolution of disputes arising under this CC~LSU shall be afforded certain review rights comparable to the ones that are provided in 42 U.S.C. §1320a-7(f) and 42 C.F.R. Part 1005 as if they applied to the Stipulated Penalties or exclusion sought pursuant to this CCA.

Specifically, DIG's determination to demand payment of Stipulated Penalties or to seek exclusion shall be subject to review by an HHS AU and, in the event of an appeal, the HHS Departmental Appeals Board (DAB), in a manner consistent with the provisions in 42 C.F.R. §§ 1005.2-1005.21. Notwithstanding the language in 42 C.F.R. § 1005.2(c), the request for a hearing involving Stipulated Penalties shall be made within 10 days after receipt ofthe Demand Letter and the request for a hearing involving exclusion shall be made within 25 days after receipt ofthe Exclusion Letter.

2. Stipulated Penalties Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for Stipulated Penalties under this CCA shall be: (a) whether LSD was in full and timely compliance with the requirements ofthis CCA for which DIG demands payment; and (b) the period of noncompliance. LSU shall have the burden of proving its full and timely compliance and the steps taken to cure the noncompliance, if any.

oro

shall not have the right to appeal to the DAB an adverse ALI decision related to

Stipulated Penalties. If the ALJ agrees with

oro

with regard

to

a finding ofa breach of this CCA and orders LSU to pay Stipulated Penalties, such Stipulated Penalties shall become due and payable 20 days after the ALI issues such a decision unless LSU requests review of the

ALI

decision by the DAB. Ifthe ALI decision is properly appealed to the DAB and the DAB upholds the determination of 010, the Stipulated Penalties shall become due and payable 20 days after the DAB issues its decision.

3. Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in

a

proceeding for exclusion based on a material breach of this CCA shall be:

a. whether LSD was in material breach of this CCA;

b. whether such breach was continuing on the date of the Exclusion Letter; and

Louisiana State University Health Science Center 10 Certification ofCompliance Agreement

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c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) LSD had begun to take action to cure the material breach within that period; (ii) LSD has pursued and is pursuing such action with due diligence; and (iii) LSD

provided to OIG within that period a reasonable timetable for curing the material breach and LSD has followed the timetable.

For purposes of the exclusion herein, exclusion shall take effect only after an ALI decision favomble to DIG, Of, ifthe ALI rules for LSD, only after a DAB decision in favor ofOIG. LSD's election ofits contmctual right to appeal to the DAB shall not abrogate OIG's authority to exclude LSD upon the issuance of an ALJ's decision in favor of 010. If the ALI sustains the determination of010 and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that LSD may request review of the ALJ decision by the DAB. If the DAB fmds in favor of 010 after an ALJ decision adverse to 010, the exclusion shall take effect 20 days after the DAB decision. LSD shall waive its right to any notice of such an exclusion ifa decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favof ofLSU, LSD shall be reinstated effective on the date of the original exclusion.

4. Finality ofDecision. The review by an ALJ or DAB provided for above shall not be considered to be an appeal right arising under any statutes or regulations. Consequently, the parties to this CCA agree that the DAB's decision (or the ALl's decision if not appealed) shall be considered final for all purposes under this CCA. IV. EFFECITVE AND BINDING AGREEMENT

LSD and 010

agree

as follows:

A. This CCA shall be binding on the suc~essors,assigns, and tmnsferees ofLSU; B. This CCA shall become fmal and binding on the date the final signature is obtained on the CCA;

C. This CCA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CCA;

D. 010 may agree to a suspension ofLSU's obligations under this CCA in the

Louisiima State University Health Science Center 11 Certification of Compliance Agreement

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event ofLSU's cessation ofparticipation in Federal health care programs. IfLSU

withdraws from participation in Federal health care programs and

is

relieved of its CCA

obligations by OIG, LSD shall notifY

oro

at least 30

days

in advance ofLSU's inteht to

reapply as a participating provider or supplier with any Federal health care program.

Upon receipt ofsuch notification, OIG shall evaluate whether the CCA should be

reactivated or modified.

E. The undersigned LSU signatory represents and warrants that he is authorized to

execute this CCA. The undersigned

010

signatory represents that he is signing this CCA

in his official capacity and that he is authorized to execute tliis CCA.

F. This CCA may be executed in counterparts, each of which constitutes an

original and all ofwhich constitute one and the same CCA. Facsimiles of signatures shall

constitute acceptable, binding signatures for purposes of this CCA.

Louisiana State University Health Science Center 12 certificationof Compliance Agreement

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GENERA COUNSEL

LSUSYSTEM

~ - J-lJ 2 DATE

ON BEHALF OF TH OFFCE OF INSPECTOR GENERAL OF TH DEPARTMNT OF HEALTH AN HUMN SERVICES

6¿g-) 9

DATE GREGORY E. DEMSKE

Assistant Inspector General for Legal Affairs

Offce of Inspector General

United States Deparment of Health and Human Services

Louisiana Stae University Health Science Center 13 Certificaon of Compliance Agreeent

May 21, 2009 P.RAYMo~LAMONICA GENERAL COUNSEL LSUSYSTEM ON BEHALF OFLSU

I:, -

J-lJ

2

DATE

ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES

GREGORYE.DEMSKE

Assistant Inspector General for LegalAffairs -Office of Inspector General

United States Department of Health and Human Services

Louisiana State University Health Science Center 13 certification ofCompliance Agreement

May21, 2009

DATE /P. Raymond Lamonica/

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Appendix A

DECLARATION

The declarant

is

currently the Corporate Compliance Officer for LSD and

has

personal knowledge ofthe

facts

stated herein. The following describes the compliance

program

(Program)

currently

in

place

at

LSD.

1. The annual budget for the Program is attached hereto as Exhibit 1 and LSU shall

sustain,

at

a minimum, the levels offunding reflected therein for three years subsequent

to

the Effective Date.

2. The Program includes a Compliance Officer who is responsible for developing

and implementing policies. procedw'es, and practices designed to ensure compliance

with

Federal health care program requirements. The Compliance Officer also

is

responsible

for monitoring the

day-to-day

compliance activities ofLSU. The Compliance Officer

is

a

member ofsenior management ofLSU and is not subordinate

to

the General Counselor

ChiefFinancial Officer. The Compliance Officer makes periodic

(at

least quarterly)

reports regarding compliance matters

to

the Audit Committee oftbe Board ofDirectors

ofLSU and is authorized to report on such matters to the Board ofDirectors

at

any time.

3. The Program includes a Compliance Committee that

is

chaired

by

the

Compliance Officer and

that

is

made up ofother members ofsenior management

ne~aryto

support the Compliance Officer

in

fulfilling her responsibilities under the

Program

~

senior executives ofrelevant departments, such as billing, clinical, human

resources, audit, and operations).

4. LSU

has in

place a Code ofConduct

that

includes: (a) LSU·s commitment to

full

compliance

with

all Federal health care program requirements, including its

commitment

to

prepare and submit accurate claims consistent

with

such requirements;

(b)

LSU's requirement

that

all ofits personnel are expected to comply with all Federal health

care program requirements and with the Policies and Procedures described

in

Paragraph 5

below: (c) the requirement that all ofLSU's personnel are expected to report to the

Compliance Officer

or other appropriate individual designated

by

LSU suspected

violations of

any

Federal health care program requirements or ofLSU's own Policies and

Procedures; (d) the possible consequences to both LSU and its personnel offallure to

comply

with

Federal health care program requirements and

with

LSU's own Policies and

Procedures and the failure to report such noncompliance; and (e) the

right

ofLSU's

Loulsfana State UniveISity Health Science Center 1

Certification of Compliance Agreement May21.2009

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pe oonel to use the Disclosure Program described in Paragraph 8 below and LSD's commitment to nonretaliation and to maintain, as appropriate, confidentiality and anonymity with respect to such disclosures. Each (i) owner, officer, director, and employee; (il) contractor, subcontractor, agent, and other person who provides patient care items or services or who performs billing or coding functions on behalf of LSU; and (iii) member of the medical staffof LSU is required to certify in writing that he or she has received, read, understood, and will abide by the Code of Conduct.

5. LSU has in place Policies and Procedures regarding the operation of the Program and LSU's compliance with Federal health care program requirements. The Policies and Procedures are distributed to all relevant LSU personnel. At least

annually

(and more frequently, ifappropriate), LSU re 'ews and updates as

necessary

its Policies and Procedures and, .ifrevisions are made, distributes the relevant portions ofany revised Policies and Procedures to all LSU personnel whose job functions relate to the revised Policies and Procedures.

6. LSD has in place an annual training program that requires all (i) owners, officers, directors, and employees; (Ii) contractors, subcontractors; agents, and other persons who provide patient care items or services or who perform billing or coding functions on behalfof LSU; and (iii) members ofthe medical staffofLSU to attend at least one hour ofannual compliance training that addresses LSU's Code ofConduct and the operation ofthe Program. LSU's annual training program also requires additional hours oftraining for all employees•.contractors. subcontractors, agents, and other persons who provide patient

care items

or services

or

who

perform

billing,

coding, or

claims submission functions. on behalfofLSU. Such additional training addresses: (a) the Federal health care program requirements regarding the accurate coding and submission of claims; (b) policies, procedures, and other requirements applicable to the

documentation of medical records; (c) the personal obligation ofeach individual involved

in the claims submission process to ensure that such claims are accurate; (d) applicable reimbursement statutes, regulations, and program requirements and directives; (e) the legal sanctions for violations ofFederal health care program requiiements; and (t)

examples ofproper and improper claims submission practices. LSD maintains written or electronic records that identify the type ofannual training provided. the date(s) ofthe training, and the attendees. Persons providing the training are knowledgeable about the subject area. LSU reviews the training content on an annual basis and, as appropriate, updates the training to reflect changes in Federal health care program requirements and/or any issues discovered during the internal audits described in Paragraph 7 below.

Louisfana State Unlversity Health ScIence Center 2 Certification ofCompUance Agreement

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,.

7. LSU has in place an internal audit department that perfonns periodic reviews to monitor LSD's compliance with Federal health care program requireme~ including focused reviews relating to specific risk areas identified by the OIG and/or through the Program; said requirement may be satisfied by utilization ofproperly trained and

credentialed compliance department staff. Annual auditing and monitoring activities are performed according to a risk based priority whjch is based on multiple factors, which include, but isnot limited to volume ofgovernmental billings, previous audit findings, published areas of regulatory interest, high risk services (such as new providers). Risk aSsessment and compliance activity priority is dynamic and modified as factors indicate.

LSU has ten (10) full-time qualified employees in its compliance department who are assigned to review LSD's compliance with Federal health care program requirements.

8. LSU maintains a Disclosure Program that includes a mechanism to enable individuals to disclose, to the Compliance Officer or some other person who is not in the disclosing individual's chain ofcommand, any identified issues or questions associated with LSU's policies, conduct, practices, or procedures with respect to a Federal health care program believed by'the individual to be

a-

potential violation ofcriminal, civil, or administrative law. LSD publicizes the existence ofthe disclosure mechanism to all personnel.

The Disclosure Program emphasizes a nonretribution, nonretallation policy and includes a reporting mechanism for anonymous communications for which appropriate confidentiality is maintained. Each disclosure is reviewed by the Compliance Officer, who either investigates the disclosure or refers the disclosure to the relevant department or manager for follow up and any appropriate corrective action.

The Compliance Officer (or designee) maintains a disclosure log, which includes a record and summary of each disclosure received (whether anonymous or not), the status ofLSU's internal review ofthe allegations, and any corrective action taken inresponse to the internal review. '

9. LSU has in place a policy and procedure for screening all prospective owners, officers, directors, employees, contractors, medical staffmembers and agents to ensure that they are not Ineligible Personsl by: (a) requiring such persons to disclose whether

I An "Ineligible Person" is an individual or entity who: (i) is currently excluded, debarred,

suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs; or (ii) has been convicted ofa

louIsiana State University Health Science Center 3 Certification ofCOmpliance Agreement

(17)

they are an Ineligible .Person; and (b) appropriately querying the General Services Administration's List ofParties Excluded from Federal Programs (available through the Internet at http://epls.arnetgov) and the HHSlOrG List ofExcluded IndividualslEntities (available through the Internet at http://oig.hhs.gov) (these lists shall hereinafter be referred to

as

the "Exclusion

Lists").

LSU

also performs annual screening ofits

current owners, officers, directors, employees, contractors,

medical

staffmembers, and agents against the Exclusion Lists and

requires

all owners,

officers,

directors, employees, contractors,

medical statt

and agents to disclose immediately any debannent, exclusion, suspension, or other event that makes ~atperson an Ineligible Person.

LSU also has a policy in place that, ifLSU has actual notice that an owner, officer, director, employee, contractor, medical

staff member,

or agent

has

become

an

Ineligtble Person, LSU will remove such person from responsibility for, or involvement with, LSU's business operations related to the Federal health care programs and will remove such person from any position for which the person's compensation or items or services furnished, ordered, or prescnoed by the person are paid in whole or in part, directly or indirectly, by Federal health care programs or otherwise with Federal funds, at least until such time as the person is reinstated into participation in the Fedeml health care

programs. (Nothing in this Declamtion affects the responsibility ofLSU to refrain from billing Federal health care programs for items or services furnished, ordered, or

prescribed by excluded individuals or LSU's liability for overpayments received by LSU as a result ofbilling any Federal health care program for such items or services.).

The undersigned signatory represents and warrants that helshe is authorized to execute this declaration on behalfofLSU.

I declare under penalty of perjury that the foregoing is true and correct. ;6

Executed on this~ day of ~, d-tJ0'1

criminal offensethatfalls within the anibit of 42 U.S.C. § 1320a-7(8), but has not yet been excluded,·debarred, suspended, or otherwise declared ineligible.

Loufsl.ana State University Health Science Center 4 Certification ofCompliance Agn:emem

(18)

~

Loui State University Health ScIenc Ceer 5

Certficaion of Compliance Agrcl1nt

May21.2009

Sus Arong

Complice Ofcer LSUHC

Lot.dsIana State University Health Science Center 5

Certifleatlon ofComplianceAgreemnt May21.2009

Susan Armstrong

(

Compliance Officer LSUHSC

/Susan Armstrong/